Keywords: cutpoint factor ; immunogenicity assay
Cutpoint factors (CPFs) for immunogenicity assays are used to distinguish samples which potentially contain anti-drug antibodies from background noise. In-study CPFs are derived from samples collected in the study prior to treatment, as opposed to CPFs derived from commercial samples or prior studies. In this presentation, we will present examples from Genentech’s current approach to the CPF lifecycle during drug development and highlight some statistical and operational challenges we observed.